Info session on applications - GMO - Technical meeting with applicants

Agenda and presentations

EFSA met with industry representatives from 26-27 November 2015 to discuss scientific, regulatory and procedural requirements related to genetically modified organisms (GMO) applications.

The event took place in the framework of EFSA’s info sessions on applications which are aimed at increasing regular interaction and exchanging of views with EFSA’s stakeholders.

Twenty-two participants representing industry working in the field of GMO met with EFSA staff, one public-private venture, one EFSA contractor, representatives of the European Union Reference Laboratory for GM Food and Feed, and a representative of the European Commission. The EFSA GMO Panel was also represented.

After a general overview on recent activities at EFSA in the field of GMO risk assessment, the following topics were discussed:

• The role of contractors in the risk assessment of GMO applications;
• Technical aspects of the methodology applied to allergen similarity searches using bioinformatics tools;
• The use of bioinformatics analysis in support of horizontal gene transfer from plants to microorganisms;
• Technical considerations of the agronomic and phenotypic characterization of genetically modified plants as specified in the recently published EFSA guidance;
• Technical aspects of the dietary exposure assessment of GMO foods;
• Recurrent issues regarding the dose selection in 28-day studies and the statistical analyses of field trials in accordance with Regulation (EC) 503/2013 and EFSA guidances;
• The importance of sampling in GM food and feed safety assessments.

Overall, participants reflected positively on the event. They considered the meeting as an important opportunity to enhance the constructive dialogue and increase mutual understanding with different actors at EFSA who are involved in the evaluation process of GM plant applications.